Introduction: For India, with a population of over 1.2 billion, there is less than one neurologist per million population and only one physiotherapist per 24,000. In rural areas, these figures are much worse.
Hypothesis: The ATTEND trial is testing the hypothesis that family-led rehabilitation can improve outcome after stroke.
Methods: The ATTEND Trial is a prospective randomised outcome blinded (PROBE design) multicentre study in India with a sample size of 1,200. Patients allocated the intervention received evidence-based rehabilitation techniques taught to a nominated family member, supported by a stroke coordinator. Patients allocated control received usual care. The primary outcome is functional independence measured by the modified Rankin Score at six months. Funding is from the Australian National Health and Medical Research Council.
Results: By August 2015, 870 patients had been randomised from 14 sites across India. For data received (n=788 baseline data, n= 345 for 6 month follow-up), the average age was 57.9 years SD 13.5 (median 59), 66% male and 91% were married. Hypertension (76%), diabetes (43%) and smoking (24%) were common risk factors. The nominated caregiver was the spouse in 44%, son/son-in-law 26%, daughter/daughter-in-law 24%. The mean NIHSS was 10, 23% of strokes were due to haemorrhage. At six months 42% were dead or dependent. Loss to follow-up is currently <1%.
Conclusions: These data illustrate the devastating effects of stroke in India with a higher proportion of haemorrhagic stroke and much younger age than typical of Western acute trial populations. The potential public health impact of a positive trial (results expected late 2016) in India is large.